A double-blind clinical study in patients with herpes zoster to establish YN-72 (Brovavir) dose.
Double-blind clinical trials were performed with a placebo to determine the optimum dose of YN-72 in patients with herpes zoster. YN-72 at 10, 50, and 100 mg was administered orally three times daily for 7 days. A total of 226 patients entered the present trial. Six of the 226 patients were excluded from statistical analysis of data. Furthermore, seven patients were excluded from the analysis for efficacy and usefulness, and included in the analysis for safety. The numbers of patients included in the analyses for efficacy and usefulness were 50 in the placebo group, 54 in the YN-72 30-mg/day group, 56 in the 150-mg/day group, and 53 in the 300-mg/day group. The numbers of patients included in analysis for safety were 53 in the placebo group, 58 in the YN-72 30-mg/day group, 56 in the 150-mg/day group and 53 in the 300-mg/day group. The effectiveness rate at the end of administration was 42.0% in the placebo group, 79.6% in the YN-72 30-mg/day group, 80.4% in the 150-mg/day group, and 61.5% in the 300-mg/day group. The rates in the YN-72 groups were significantly higher than in the placebo group. Evaluation at the end of the trials revealed that administration of YN-72 was effective. Among skin symptoms, administration of YN-72 accelerated the disappearance of erythema and vesicles and the formation of crust. Administration of YN-72 tended to accelerate the reduction and disappearance of pain. Reduction and disappearance in the YN-72 150-mg/day group occurred significantly earlier than in the placebo group (log-rank test).(ABSTRACT TRUNCATED AT 250 WORDS)
Niimura
M
M
Department of Dermatology, Jikei University School of Medicine, Tokyo.
D000328:Adult; D000698:Analgesia; D000998:Antiviral Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001086:Arabinofuranosyluracil / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D006562:Herpes Zoster / Q000188:drug therapy*; D006801:Humans; D010919:Placebos
D000998:Antiviral Agents; D010919:Placebos; D001086:Arabinofuranosyluracil; C031368:sorivudine